Depuy P.F.C. SIGMA curved insert recallZ-1163-05 · 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-1163-05
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: 18
Product code: JWH
FDA submissions: K033272
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. SIGMA curved insert; polyethylene tibial insert, Sz 4, 8 mm; Ref 1581-14-008.

Code information (models, lots, serial numbers)

Lots XY7B84 and Y5RDJ4.

Other devices under the same FDA submission

65 devices cleared under K033272 — 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 1581-22-010
Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
23 reports
P.F.C. SIGMA 1581-23-010
Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
21 reports
P.F.C. SIGMA 1581-24-010
Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
18 reports
P.F.C. SIGMA 1581-14-008
Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
17 reports
P.F.C. SIGMA 1581-14-010
Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
17 reports
P.F.C. SIGMA 1581-13-008
Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
15 reports
P.F.C. SIGMA 1581-23-008
Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
14 reports
P.F.C. SIGMA 1581-12-008
Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
13 reports
P.F.C. SIGMA 1581-13-010
Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
13 reports
P.F.C. SIGMA 1581-24-008
Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
13 reports
P.F.C. SIGMA 1581-21-008
Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
12 reports
P.F.C. SIGMA 1581-22-008
Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
12 reports

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-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.
Z-1184-05 · Terminated
Depuy P.F.C. SIGMA stabilized insert; polyethylene tibial insert, Sz 4, 8 mm; Ref 1581-24-008.

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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