Medical Device Recalls

39,072 Records

FDA medical device enforcement reports

1,565 results found for sterilization Page 57 of 63
Integra York PA, Inc
Class II Terminated
Integra Container Lid, ¿¿ Size, Red; Container Lid, ¿¿ Size, Blue; Container Lid, ¿¿ Size, Red; Container Lid, ¿¿ Size, Gold; Container Lid, ¿¿ Size, Green; Container Lid, Full Size, Blue; ...
Reason: Integra LifeSciences has identified through an internal investigation that some colored lids for Integra container systems were not yet cleared by the FDA for sale and were inadve...
Z-2624-2014 September 17, 2014 York, PA
Zimmer, Inc.
Class II Terminated
PERSONA (TM) The Personalized Knee System Tibial General Instrument Tray, non-sterile The intended use of the sterilization case is to organize, store and protect its contents from damage consisten...
Reason: The firm discovered that the current Personal Tibial/General Fixed Bracket Trays may not have the specific geometry to accommodate the tibial drill and stop guide with proper posit...
Z-2289-2014 August 27, 2014 Warsaw, IN
Zimmer, Inc.
Class II Terminated
PERSONA (TM) The Personalized Knee System Tibial General Instrument Tray, non-sterile The intended use of the sterilization case is to organize, store and protect its contents from damage consisten...
Reason: The firm discovered that the current Personal Tibial/General Fixed Bracket Trays may not have the specific geometry to accommodate the tibial drill and stop guide with proper posit...
Z-2288-2014 August 27, 2014 Warsaw, IN
Medtronic Neuromodulation
Class II Terminated
Medtronic, Activa PC, Model 37601, Method of Sterilization: Ethylene Oxide, Single Use Only, Rx Only. The Activa¿ PC neurostimulator is a dual-channel device capable of delivering bilateral stimu...
Reason: Medtronic is recalling six Activa PC (model 37601) Implantable Neurostimulators due to the potential for a damaged electrical component during manufacturing.
Z-2259-2014 August 27, 2014 Minneapolis, MN
Innovasis, Inc
Class II Terminated
Excella II Standard Pedicle Screw, Catalog No. E2S47525 and E2S47535, 4.75 mm x 25 mm. For spinal fixation. Packaged in heat-sealed plastic bag. Also provided in reusable steam sterilization tray as...
Reason: Innovasis is recalling the Excella II Standard Pedicle Screw due to mislabeling of the size and catalog number.
Z-2067-2014 July 23, 2014 Salt Lake City, UT
3M Company - Health Care Business
Class II Terminated
3M Attest Auto-reader. Model numbers 390, 390G,and 490. These devices incubate the biological indicators (BIs) to determine a positive or negative result for the sterilization cycle.
Reason: Labeling on units shipped prior to May 16th, 2014 did not contain the statement "This product contains dry natural rubber" as required by the United States Food and Drug Administra...
Z-2002-2014 July 16, 2014 Saint Paul, MN
Stryker Endoscopy
Class II Terminated
Shaver Handpiece Sterilization Tray. Model number 272-700-000. For sterilization of Stryker Endoscopy arthroscopic shaver.
Reason: STERRAD 100S parameters provided in the Shaver Handpiece reprocessing guide (P10299 Revision A) did not fully consider all worst-case scenarios during validation testing.
Z-1872-2014 July 2, 2014 San Jose, CA
Medline Industries Inc
Class II Terminated
Esmark Elastic Bandage (Sterile), 4" x 9'. Item DYNJ05116A, Individually wrapped, 20 bandages per case. Packaged by Medline Industries Inc. This product is used as an elastic bandage to support and co...
Reason: This lot did not go through the correct sterilization procedures. This product may potentially be non-sterile.
Z-1649-2014 May 28, 2014 Mundelein, IL
Stryker Endoscopy
Class II Terminated
12-Instrument Sterilization Tray; Product Usage: The 12-Instrument Tray is used to hold and protect surgical instruments during the sterilization process. Specifically, this tray is used for the C...
Reason: Gravity sterilization parameters provided in the 12 Instrument Sterilization reprocessing guide did not fully consider all worst-case scenarios during validation testing.
Z-1544-2014 May 14, 2014 San Jose, CA
Zimmer, Inc.
Class II Terminated
Natural-Knee¿ N-K II DOMED ALL-POLY PAT, SZ0 N-K II DOMED ALL-POLY PAT, SZ1
Reason: A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the discoloration was the result of free radical oxidation. The oxidation process was adva...
Z-1249-2014 March 26, 2014 Warsaw, IN
Zimmer, Inc.
Class II Terminated
Natural-Knee¿ II Posterior Stabilized (P.S.) Condylar Tibial Inserts: N-K II CONS PS TIB INS SZ N-K II CONS PS TIB INS SZ N-K II CONS PS TIB INS SZ N-K II CONS PS TIB INS SZ N-K II CONS PS TIB I...
Reason: A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the discoloration was the result of free radical oxidation. The oxidation process was adva...
Z-1257-2014 March 26, 2014 Warsaw, IN
Zimmer, Inc.
Class II Terminated
Gender Solutions" Natural-Knee¿ Flex System: N-K FLEX MBACK SZ 0 PAT N-K FLEX MBACK SZ 1 PAT N-K FLEX MBACK SZ 2 PAT
Reason: A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the discoloration was the result of free radical oxidation. The oxidation process was adva...
Z-1248-2014 March 26, 2014 Warsaw, IN
Zimmer, Inc.
Class II Terminated
Natural-Knee¿ II System ULTRA CONG INS LT SZA/9MM ULTRA CONG INS LT SZA/13M ULTRA CONG INS LT SZA/19M ULTRA CONG INS RT SZA/9MM ULTRA CONG INS RT SZA/11M ULTRA CONG INS RT SZA/13M ULTRA CONG I...
Reason: A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the discoloration was the result of free radical oxidation. The oxidation process was adva...
Z-1255-2014 March 26, 2014 Warsaw, IN
Zimmer, Inc.
Class II Terminated
Natural-Knee¿ II Unicompartmental Knee System: UNI ALL-POLY TIB SZ 1-7mm UNI ALL-POLY TIB SZ 1-9mm
Reason: A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the discoloration was the result of free radical oxidation. The oxidation process was adva...
Z-1252-2014 March 26, 2014 Warsaw, IN
Zimmer, Inc.
Class II Terminated
Natural-Knee¿ Congruent Tibial Insert with Screw: SF-CON TIB INS LT SZ1/2 1 SF-CON TIB INS RT SZ1/2 9 SF-CON TIB INS RT SZ3/4/5
Reason: A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the discoloration was the result of free radical oxidation. The oxidation process was adva...
Z-1254-2014 March 26, 2014 Warsaw, IN
Zimmer, Inc.
Class II Terminated
MOST Options" System (MOST) HINGED TIB INS SZ 1 16MM HINGED TIB INS SZ 4 6MM M HINGED TIB INS SZ 4 9MM M HINGED TIB INS SZ 4 16MM MOST PROX TIB INS 6MM
Reason: A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the discoloration was the result of free radical oxidation. The oxidation process was adva...
Z-1250-2014 March 26, 2014 Warsaw, IN
Zimmer, Inc.
Class II Terminated
Natural-Knee¿ II Constrained Knee System NKII CCK TIB INS SZ00/0-L NKII CCK TIB INS SZ1/2-LF NKII CCK TIB INS SZ3-5 -L NKII CCK TIB INS SZ00/0-R NKII CCK TIB INS SZ3-5 -R NKII CCK TIB INS SZ1/2...
Reason: A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the discoloration was the result of free radical oxidation. The oxidation process was adva...
Z-1256-2014 March 26, 2014 Warsaw, IN
Zimmer, Inc.
Class II Terminated
Natural-Knee¿ II System: POLY ULTRA TIB LT SZ00/9M POLY ULTRA TIB LT SZ0/9MM POLY ULTRA TIB LT SZ0/19M POLY ULTRA TIB RT SZ0/13M POLY ULTRA TIB RT SZ0/16M ALL POLY ULTRA TIB LT SZ1 ALL POLY UL...
Reason: A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the discoloration was the result of free radical oxidation. The oxidation process was adva...
Z-1262-2014 March 26, 2014 Warsaw, IN
Zimmer, Inc.
Class II Terminated
Apollo" Revision/Constrained Knee System: SZ0-16MM AK CCK TIB INSER SZ1-11MM AK CCK TIB INSER SZ1-16MM AK CCK TIB INSER SZ1-22MM AK CCK TIB INSER SZ1-30MM AK CCK TIB INSER SZ2-11MM AK CCK TIB IN...
Reason: A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the discoloration was the result of free radical oxidation. The oxidation process was adva...
Z-1261-2014 March 26, 2014 Warsaw, IN
Zimmer, Inc.
Class II Terminated
Apollo" Knee System: PS TIB INS SZ0/16MM APOLL PS TIB INS SZ0/19MM APOLL PS TIB INS SZ0/22MM APOLL PS TIB INS SZ1/16MM APOLL PS TIB INS SZ2/16M APOLLO PS TIB INS SZ2/22MM APOLL PS TIB INS SZ3/1...
Reason: A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the discoloration was the result of free radical oxidation. The oxidation process was adva...
Z-1260-2014 March 26, 2014 Warsaw, IN
Zimmer, Inc.
Class II Terminated
Apollo" Knee System: APOLLO PATELLA SZ0 28MM R
Reason: A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the discoloration was the result of free radical oxidation. The oxidation process was adva...
Z-1258-2014 March 26, 2014 Warsaw, IN
Zimmer, Inc.
Class II Terminated
Natural-Knee¿ II - Unicompartmental Knee Prosthesis: CONG TIB INS SZ1/2 9MM UN CONG TIB INS SZ1/2 11MM U CONG TIB INS SZ1/2 13MM U CONG TIB INS SZ3/4 9MM UN CONG TIB INS SZ3/4 11MM U CONG TIB I...
Reason: A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the discoloration was the result of free radical oxidation. The oxidation process was adva...
Z-1251-2014 March 26, 2014 Warsaw, IN
Zimmer, Inc.
Class II Terminated
Apollo Knee Tibial Baseplate/Knee Tibial Insert: CONG TIB INS SZ0/19MM APO CONG TIB INS SZ0/22MM APO CONG TIB INS SZ1/9MM APOL CONG TIB INS SZ1/11MM APO CONG TIB INS SZ1/19MM APO CONG TIB INS SZ...
Reason: A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the discoloration was the result of free radical oxidation. The oxidation process was adva...
Z-1259-2014 March 26, 2014 Warsaw, IN
Zimmer, Inc.
Class II Terminated
Natural-Knee¿/Apollo" Knee: M/B PAT SZ0 NATURAL-KNEE M/B PAT SZ1 NATURAL-KNEE M/B PAT SZ2 NATURAL-KNEE
Reason: A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the discoloration was the result of free radical oxidation. The oxidation process was adva...
Z-1253-2014 March 26, 2014 Warsaw, IN
Biomet 3i, LLC
Class II Terminated
Navigator Surgical Kit Product Usage: Molded plastic tray used in holding various dental instruments for autoclave processing.
Reason: During recent revised sterilization validation testing, the included surgical trays did not meet the Sterility Assurance Level required.
Z-1167-2014 March 19, 2014 Palm Beach Gardens, FL