Stanmore modular hip system recallZ-1281-03 · Biomet, Inc. · initiated Jun 18, 2003
Terminated All recalls posted in September 2003
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 Biomet, 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
The labeling does not instruct the removal of the protective shipping cap, and one surgeon implanted with the cap still in place.
FDA root cause category: Other
What the company is doing
Distributors were sent a letter on June 18, 2003 via FedEx. This mailing contained labels and the distributors were instructed to affix the label to the inventory consigned to hospitals within their territory.
Recall details
- Recall number
- Z-1281-03
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Jun 18, 2003
- Posted by the FDA
- Sep 24, 2003
- Recalling firm
- Biomet, Inc.
- Quantity
- 16
- Product code
- JDI
- FDA submissions
- K911684
- Distribution
- United States
Product description
Stanmore modular hip system; Stanmore CoCr femoral size 1 std. stem; part 164241
Code information (models, lots, serial numbers)
lots 323846, 342260, 352799, 377954, 404867, 434003, 442086, 442087, 442088, 448410, 469963, 469966
Other devices under the same FDA submission
9 devices cleared under K911684 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- BIOMET HIP SYSTEM 163668Biomet Orthopedics, LLC · Prosthesis, hip, semi-constrained, metal/polymer, cemented6 reports
- BIOMET HIP SYSTEM 163660Biomet Orthopedics, LLC · Prosthesis, hip, semi-constrained, metal/polymer, cemented4 reports
- BIOMET HIP SYSTEM 163663Biomet Orthopedics, LLC · Prosthesis, hip, semi-constrained, metal/polymer, cemented3 reports
- BIOMET HIP SYSTEM 163670Biomet Orthopedics, LLC · Prosthesis, hip, semi-constrained, metal/polymer, cemented2 reports
- BIOMET HIP SYSTEM 163669Biomet Orthopedics, LLC · Prosthesis, hip, semi-constrained, metal/polymer, cemented2 reports
- BIOMET HIP SYSTEM 163661Biomet Orthopedics, LLC · Prosthesis, hip, semi-constrained, metal/polymer, cemented1 report
- BIOMET HIP SYSTEM 163672Biomet Orthopedics, LLC · Prosthesis, hip, semi-constrained, metal/polymer, cemented1 report
- BIOMET HIP SYSTEM 163665Biomet Orthopedics, LLC · Prosthesis, hip, semi-constrained, metal/polymer, cemented1 report
- BIOMET HIP SYSTEM 163666Biomet Orthopedics, LLC · Prosthesis, hip, semi-constrained, metal/polymer, cemented1 report
Other products in the same recall event
The FDA groups related products into one recall event (event 26618).
- Z-1282-03 · TerminatedStanmore modular hip system; Stanmore CoCr femoral size 2 std. stem; part 164242
- Z-1283-03 · TerminatedStanmore modular hip system; Stanmore CoCr femoral size 3 std. stem; part 164243
- Z-1284-03 · TerminatedStanmore modular hip system; Stanmore CoCr femoral size 4 std. stem; part 164244
- Z-1285-03 · TerminatedStanmore modular hip system; Stanmore CoCr femoral size 5 std. stem; part 164245
- Z-1286-03 · TerminatedStanmore modular hip system; Stanmore CoCr femoral size 1 straight stem; part 164251
- Z-1287-03 · TerminatedStanmore modular hip system; Stanmore CoCr femoral size 2 straight stem; part 164252
- Z-1288-03 · TerminatedStanmore modular hip system; Stanmore CoCr femoral size 3 straight stem; part 164253
- Z-1289-03 · TerminatedStanmore modular hip system; Stanmore CoCr femoral size 4 straight stem; part 164254
- Z-1290-03 · TerminatedStanmore modular hip system; Stanmore CoCr femoral size 5 straight stem; part 164255
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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