VerSys Hip System, Beaded Fullcoat Stems, Zimmer, Inc.… recallZ-1842-2014 · Zimmer, Inc. · initiated May 19, 2014
Class II Terminated All recalls posted in June 2014
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 Zimmer, 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
During routine inspection, beaded hip stem forgings received from supplier failed to meet ZES 2A-102. Processing of Beaded CoCrMo Alloy Hip Stem, material requirements per ATS #14-04818 and ATS #14-05549, respectively.
FDA root cause category: Nonconforming Material/Component
What the company is doing
On 6/2/2014 the firm sent "Urgent Medical Device Recall" letters to their customers. On 8/13/14, Zimmer contacted a distributor via phone pertaining to one additional lot (00-7843-011-06; lot 62547211) which had been included in the recall. Formal recall notices were issued to the distributor via email on 8/15/14.
Recall details
- Recall number
- Z-1842-2014
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- May 19, 2014
- Posted by the FDA
- Jun 20, 2014
- Recalling firm
- Zimmer, Inc.
- Quantity
- 147 units
- Product code
- LPH
- FDA submissions
- K973714
- Distribution
- Worldwide Distribution-USA (nationwide) including the states of AL, AZ, CA, CO, CT, FL, GA, IL, IN, MA, MI, MN, NC, ND, NJ, NY, OH, OK, PA, TN, TX, VA & WI, and the countries of Canada, Colombia, Dominican Republic, Japan, Korea (S. Korea), Peru, Taiwan & Thailand.
Product description
VerSys Hip System, Beaded Fullcoat Stems, Zimmer, Inc., Warsaw, IN 46581
Code information (models, lots, serial numbers)
Item # 784301108, Lot #'s: 62478967, 62479742, 62503408, 62528282, 62530786, 62544915, 62554360; Item # 784301126, Lot #: 62544885, 62547211, Item # 784301156, Lot #, 62587079; Item # 784301208, Lot #'s: 62503411, 62509385, 62530790, 62547217, 62554362; Item # 784301226, Lot #'s: 62515502, 62547216; Item # 784301256, Lot #'s: 62489572, 62522386; Item # 784301326, Lot #, 62496464, 62594428, 62622893; Item # 784301356, Lot #: 62622894; Item # 784301382, Lot #: 62544907; Item # 784301511, Lot #: 62472423 & Item # 784301581, Lot #: 62496469.
Other devices under the same FDA submission
4 devices cleared under K973714 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- VerSys® 7843-13-06Zimmer, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED2 reports
- VerSys® 7843-11-26Zimmer, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 report
- VerSys® 7843-12-26Zimmer, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 report
- VerSys® 7843-17-36Zimmer, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 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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