Biomet Integral Centralizer Hip System, Lateralized Femoral… recallZ-0650-2016 · Biomet, Inc. · initiated Nov 17, 2015
Class II Terminated All recalls posted in January 2016
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
PMMA is listed as a material on the label but the product does not contain PMMA.
FDA root cause category: Labeling Change Control
What the company is doing
On 11/17/2015, URGENT MEDICAL DEVICE RECALL NOTICE notifications were sent to the affected distributors via courier with instructions for identifying and returning the affected product. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Questions related to this notice should be directed to (574) 372-1570, Monday through Friday, 8 a.m. to 5 p.m.
Recall details
- Recall number
- Z-0650-2016
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Nov 17, 2015
- Posted by the FDA
- Jan 13, 2016
- Recalling firm
- Biomet, Inc.
- Quantity
- 21
- Product code
- LZO
- FDA submissions
- K942479
- Distribution
- Worldwide distribution. US nationwide including IA, UT, MN, PA, MO, OK, IL, OH, and WA; CANADA, and NETHERLANDS
Product description
Biomet Integral Centralizer Hip System, Lateralized Femoral Stem (Co-Cr-Mo), 9mm, 11mm, 13mm, 15mm, and 17mm
Code information (models, lots, serial numbers)
Part #11-162709 9mm Lots: 329750, 404380, 487400, 767120, 951680 Part # 11-162711 11mm Lots: 329760, 505030, 505050 Part # 11-162713 13mm Lots: 837750, 977460 Part # 11-162715 15mm 772410, 837780, 897070, 951810 Part # 11-162717 17mm Lots: 311410, 410500, 535530, 712800, 728080, 829580
Other devices under the same FDA submission
9 devices cleared under K942479 — 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
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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