Depuy P.F.C. Modular Knee System, curved tibial insert (CVD) recallZ-1336-05 · Depuy Orthopaedics, Inc. · initiated May 26, 2005

Terminated All recalls posted in August 2005

Is my device affected?

Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
If yours is listed, follow the instructions from Depuy Orthopaedics, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Other

Recall details

Recall number: Z-1336-05
Recall class: Not yet classified by the FDA
Status: Terminated
Initiated by the company: May 26, 2005
Posted by the FDA: Aug 12, 2005
Recalling firm: Depuy Orthopaedics, Inc.
Quantity: 10
Product code: JWH
FDA submissions: K884796
Distribution: Nationwide, Argentina, Brazil, Canada, Caguas, Colombia, Ireland, Malaysia, Mexico, Panama, Peru, Singapore, South Africa, Sweden, Uruguay and Venezuela.

Product description

Depuy P.F.C. Modular Knee System, curved tibial insert (CVD); polyethylene tibial insert, Sz 4, 8.0 mm; Ref 98-4152.

Code information (models, lots, serial numbers)

Lot 84237A.

Other devices under the same FDA submission

18 devices cleared under K884796 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

P.F.C. SIGMA 86-6023
Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
29 reports
P.F.C. SIGMA 86-6024
Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
25 reports
P.F.C. SIGMA 86-6029
Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
20 reports
P.F.C. SIGMA 86-6022
Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
16 reports
P.F.C. SIGMA 86-6025
Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
14 reports
P.F.C. 86-0123
Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
9 reports
P.F.C. 86-0124
Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
4 reports
P.F.C. 86-0122
Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
3 reports
P.F.C. 86-0127
Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
3 reports
P.F.C. 86-0125
Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
2 reports
P.F.C. 98-4149
Depuy Orthopaedics, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
2 reports
P.F.C. 86-0126
Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
1 report

Other products in the same recall event

The FDA groups related products into one recall event (event 32192).

Z-1154-05 · Terminated
Depuy P.F.C. SIGMA curved insert; polyethylene tibial insert, Sz 2, 8 mm; Ref 1581-11-008.
Z-1155-05 · Terminated
Depuy P.F.C. SIGMA curved insert; polyethylene tibial insert , Sz 2.5, 8 mm; Ref 1581-12-008.
Z-1156-05 · Terminated
Depuy P.F.C. SIGMA curved insert; polyethylene tibial insert, Sz 2.5, 10 mm; Ref 1581-12-010.
Z-1157-05 · Terminated
Depuy P.F.C. SIGMA curved insert; polyethylene tibial insert, Sz 2.5, 17.5 mm; Ref 1581-12-017.
Z-1158-05 · Terminated
Depuy P.F.C. SIGMA curved insert; polyethylene tibial insert, Sz 3, 8 mm; Ref 1581-13-008.
Z-1159-05 · Terminated
Depuy P.F.C. SIGMA curved insert; polyethylene tibial insert, Sz 3, 10 mm; Ref 1581-13-010.
Z-1160-05 · Terminated
Depuy P.F.C. SIGMA curved insert; polyethylene tibial insert, Sz 3, 15 mm; Ref 1581-13-015.
Z-1161-05 · Terminated
Depuy P.F.C. SIGMA curved insert; polyethylene tibial insert, Sz 3, 17.5 mm; Ref 1581-13-017.
Z-1162-05 · Terminated
Depuy P.F.C. SIGMA curved insert; polyethylene tibial insert, Sz 3, 20 mm; Ref 1581-13-020.
Z-1163-05 · Terminated
Depuy P.F.C. SIGMA curved insert; polyethylene tibial insert, Sz 4, 8 mm; Ref 1581-14-008.
Z-1164-05 · Terminated
Depuy P.F.C. SIGMA curved insert; polyethylene tibial insert, Sz 4,10 mm; Ref 1581-14-010.
Z-1165-05 · Terminated
Depuy P.F.C. SIGMA curved insert; polyethylene tibial insert, Sz 4, 15 mm; Ref 1581-14-015.
Z-1166-05 · Terminated
Depuy P.F.C. SIGMA curved insert; polyethylene tibial insert, Sz 4, 17.5 mm; Ref 1581-14-017.
Z-1167-05 · Terminated
Depuy P.F.C. SIGMA curved insert; polyethylene tibial insert, Sz 5, 8 mm; Ref 1581-15-008.
Z-1168-05 · Terminated
Depuy P.F.C. SIGMA curved insert; polyethylene tibial insert, Sz 5, 10 mm; Ref 1581-15-010.
Z-1169-05 · Terminated
Depuy P.F.C. SIGMA curved insert; polyethylene tibial insert, Sz 5, 12.5 mm; Ref 1581-15-012.
Z-1170-05 · Terminated
Depuy P.F.C. SIGMA curved insert; polyethylene tibial insert, Sz 5, 15 mm; Ref 1581-15-015.
Z-1171-05 · Terminated
Depuy P.F.C. SIGMA curved insert; polyethylene tibial insert, Sz 5, 17.5 mm; Ref 1581-15-017.
Z-1172-05 · Terminated
Depuy P.F.C. SIGMA curved insert; polyethylene tibial insert, Sz 6, 12.5 mm; Ref 1581-16-012.
Z-1173-05 · Terminated
Depuy P.F.C. SIGMA stabilized insert; polyethylene tibial insert, Sz 1.5, 8 mm; Ref 1581-20-008.
Z-1174-05 · Terminated
Depuy P.F.C. SIGMA stabilized insert; polyethylene tibial insert, Sz 1.5, 15 mm; Ref 1581-20-015.
Z-1175-05 · Terminated
Depuy P.F.C. SIGMA stabilized insert; polyethylene tibial insert, Sz 2, 15 mm; Ref 1581-21-015.
Z-1176-05 · Terminated
Depuy P.F.C. SIGMA stabilized insert; polyethylene tibial insert, Sz 2, 20 mm; Ref 1581-21-020.
Z-1177-05 · Terminated
Depuy P.F.C. SIGMA stabilized insert; polyethylene tibial insert, Sz 2.5, 8 mm; Ref 1581-22-008.
Z-1178-05 · Terminated
Depuy P.F.C. SIGMA stabilized insert; polyethylene tibial insert, Sz 2.5, 10 mm; Ref 1581-22-010.
Z-1179-05 · Terminated
Depuy P.F.C. SIGMA stabilized insert; polyethylene tibial insert, Sz 2.5, 12.5 mm; Ref 1581-22-012.
Z-1180-05 · Terminated
Depuy P.F.C. SIGMA stabilized insert; polyethylene tibial insert, Sz 3, 10 mm; Ref 1581-23-010.
Z-1181-05 · Terminated
Depuy P.F.C. SIGMA stabilized insert; polyethylene tibial insert, Sz 3, 12.5 mm; Ref 1581-23-012.
Z-1182-05 · Terminated
Depuy P.F.C. SIGMA stabilized insert; polyethylene tibial insert, Sz 3, 15 mm; Ref 1581-23-015.
Z-1183-05 · Terminated
Depuy P.F.C. SIGMA stabilized insert; polyethylene tibial insert, Sz 3, 17.5 mm; Ref 1581-23-017.

Sources and updates

Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.

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