Depuy Sigma Tibial Inserts

• 12 recalls, same reason

  • Terminated Z-0412-2014 FDA Class II ·initiated 18 Nov 2013
  • Terminated Z-0417-2014 FDA Class II ·initiated 18 Nov 2013
  • Terminated Z-0416-2014 FDA Class II ·initiated 18 Nov 2013
  • Terminated Z-0414-2014 FDA Class II ·initiated 18 Nov 2013
  • Terminated Z-0413-2014 FDA Class II ·initiated 18 Nov 2013
  • Terminated Z-0420-2014 FDA Class II ·initiated 18 Nov 2013
  • Terminated Z-0422-2014 FDA Class II ·initiated 18 Nov 2013 ·on shared 510(k) K033272
  • Terminated Z-0421-2014 FDA Class II ·initiated 18 Nov 2013 ·on shared 510(k) K033272
  • Terminated Z-0419-2014 FDA Class II ·initiated 18 Nov 2013
  • Terminated Z-0415-2014 FDA Class II ·initiated 18 Nov 2013
  • Terminated Z-0423-2014 FDA Class II ·initiated 18 Nov 2013
  • Terminated Z-0418-2014 FDA Class II ·initiated 18 Nov 2013

  DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Knee Instrument because of the potential for tabs on the connection end to fracture and be left in the patient.

• 39 recalls, same reason

  • Terminated Z-1163-05 FDA Unclassified (pre-2012) ·initiated 26 May 2005
  • Terminated Z-1167-05 FDA Unclassified (pre-2012) ·initiated 26 May 2005
  • Terminated Z-1179-05 FDA Unclassified (pre-2012) ·initiated 26 May 2005
  • Terminated Z-1189-05 FDA Unclassified (pre-2012) ·initiated 26 May 2005
  • Terminated Z-1156-05 FDA Unclassified (pre-2012) ·initiated 26 May 2005
  • Terminated Z-1177-05 FDA Unclassified (pre-2012) ·initiated 26 May 2005
  • Terminated Z-1168-05 FDA Unclassified (pre-2012) ·initiated 26 May 2005
  • Terminated Z-1188-05 FDA Unclassified (pre-2012) ·initiated 26 May 2005
  • Terminated Z-1155-05 FDA Unclassified (pre-2012) ·initiated 26 May 2005
  • Terminated Z-1191-05 FDA Unclassified (pre-2012) ·initiated 26 May 2005
  • Terminated Z-1170-05 FDA Unclassified (pre-2012) ·initiated 26 May 2005
  • Terminated Z-1176-05 FDA Unclassified (pre-2012) ·initiated 26 May 2005
  • Terminated Z-1165-05 FDA Unclassified (pre-2012) ·initiated 26 May 2005
  • Terminated Z-1187-05 FDA Unclassified (pre-2012) ·initiated 26 May 2005
  • Terminated Z-1181-05 FDA Unclassified (pre-2012) ·initiated 26 May 2005
  • Terminated Z-1180-05 FDA Unclassified (pre-2012) ·initiated 26 May 2005
  • Terminated Z-1164-05 FDA Unclassified (pre-2012) ·initiated 26 May 2005
  • Terminated Z-1174-05 FDA Unclassified (pre-2012) ·initiated 26 May 2005
  • Terminated Z-1157-05 FDA Unclassified (pre-2012) ·initiated 26 May 2005
  • Terminated Z-1154-05 FDA Unclassified (pre-2012) ·initiated 26 May 2005
  • Terminated Z-1186-05 FDA Unclassified (pre-2012) ·initiated 26 May 2005
  • Terminated Z-1183-05 FDA Unclassified (pre-2012) ·initiated 26 May 2005
  • Terminated Z-1173-05 FDA Unclassified (pre-2012) ·initiated 26 May 2005
  • Terminated Z-1185-05 FDA Unclassified (pre-2012) ·initiated 26 May 2005
  • Terminated Z-1175-05 FDA Unclassified (pre-2012) ·initiated 26 May 2005
  • Terminated Z-1182-05 FDA Unclassified (pre-2012) ·initiated 26 May 2005
  • Terminated Z-1166-05 FDA Unclassified (pre-2012) ·initiated 26 May 2005
  • Terminated Z-1171-05 FDA Unclassified (pre-2012) ·initiated 26 May 2005
  • Terminated Z-1192-05 FDA Unclassified (pre-2012) ·initiated 26 May 2005
  • Terminated Z-1184-05 FDA Unclassified (pre-2012) ·initiated 26 May 2005
  • Terminated Z-1190-05 FDA Unclassified (pre-2012) ·initiated 26 May 2005
  • Terminated Z-1161-05 FDA Unclassified (pre-2012) ·initiated 26 May 2005
  • Terminated Z-1172-05 FDA Unclassified (pre-2012) ·initiated 26 May 2005
  • Terminated Z-1158-05 FDA Unclassified (pre-2012) ·initiated 26 May 2005
  • Terminated Z-1178-05 FDA Unclassified (pre-2012) ·initiated 26 May 2005
  • Terminated Z-1159-05 FDA Unclassified (pre-2012) ·initiated 26 May 2005
  • Terminated Z-1169-05 FDA Unclassified (pre-2012) ·initiated 26 May 2005
  • Terminated Z-1160-05 FDA Unclassified (pre-2012) ·initiated 26 May 2005
  • Terminated Z-1162-05 FDA Unclassified (pre-2012) ·initiated 26 May 2005

  An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

1. 18 Nov 2013 Recall initiated FDA recalls Z-0416-2014
2. 18 Nov 2013 Recall initiated FDA recalls Z-0414-2014
3. 18 Nov 2013 Recall initiated FDA recalls Z-0413-2014
4. 18 Nov 2013 Recall initiated FDA recalls Z-0420-2014
5. 18 Nov 2013 Recall initiated FDA recalls Z-0422-2014
6. 18 Nov 2013 Recall initiated FDA recalls Z-0421-2014
7. 18 Nov 2013 Recall initiated FDA recalls Z-0419-2014
8. 18 Nov 2013 Recall initiated FDA recalls Z-0415-2014
9. 18 Nov 2013 Recall initiated FDA recalls Z-0423-2014
10. 18 Nov 2013 Recall initiated FDA recalls Z-0418-2014

42 earlier events are in the sections above.

510(k) Number

K033272 ↗

FDA product code

JWH

Device class

Class II

Regulation

21 CFR Part 888.3560

Advisory committee

Orthopedic

FDA decision

SESE Substantially Equivalent

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Source: 510k-lineage (choiben314), CC BY 4.0

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

• S-Rom

  Class III

  CE/MDD

• Global Advantage

  Class III

  CE/MDD

• Duraloc MARATHON

  Class III

  CE/MDD

• Pinnacle Porocoat

  Class III

  CE/MDD

See all devices from Depuy Orthopaedics, Inc. →