Zimmer Biomet Ceramic Head, 22.2 mm Diameter, 12/14 Taper, +3 Neck, Model Number 802602203; Prosthesis, Hip, Semi-Constrained, Metal/Cerami…
Zimmer, Inc. · The associated product labeling does not adequately provide compatibility information for use of the 22.2 mm Diameter Ceramic Femoral Heads with cobalt-chrome…
Open FDA's page for this record- Cfres ID
- 213137
- Product res number
- Z-1646-2025
- Event date initiated
- 2025-03-24
- Event date posted
- 2025-04-21
- Recall status
- Open, Classified
- Res event number
- 96493
- Product code
- LZO
- Code info
- GTIN 00887868376337, All lots distributed with IFU 87-6204-051-99 Rev D or prior
- Firm FEI number
- 1000220733
- Recalling firm
- Zimmer, Inc.
- Address 1
- 1800 W Center St
- City
- Warsaw
- State
- IN
- Postal code
- 46580-2304
- Additional info contact
- 411 Technical Services 574-267-6131
- Root cause description
- Under Investigation by firm
- Product quantity
- 215 units
- Distribution pattern
- Worldwide distribution - US Nationwide and the countries of Panama, Hong Kong, China.
- Product description
Zimmer Biomet Ceramic Head, 22.2 mm Diameter, 12/14 Taper, +3 Neck, Model Number 802602203; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non- Porous, Uncemented
- Reason for recall
The associated product labeling does not adequately provide compatibility information for use of the 22.2 mm Diameter Ceramic Femoral Heads with cobalt-chrome femoral stems or stainless-steel femoral stems.
- Action
Zimmer Biomet issued an URGENT MEDICAL DEVICE RECALL CORRECTION - PHASE 1 notice to its consignees on 03/24/2025 via email and courier. The notice explains the issue, potential risk, and requested the following: Distributors: Your Responsibilities 1. Review this notification and ensure that affected team members are aware of the contents. 2. Complete Attachment 1 Certificate of Acknowledgement and send to CorporateQuality.PostMarket@zimmerbiomet.com. 3. Return the Additional Accounts form to CorporateQuality.PostMarket@zimmerbiomet.com. a. Review the list of hospitals and/or surgeons included with the email notification sent to your facility, which includes a list of hospitals and/or surgeons that have already been notified of this recall. b. Identify whether there are any additional hospitals and/or surgeons that Zimmer Biomet has not notified and list these accounts on the Additional Accounts form. Please provide the form in Excel format. c. If there are no additional accounts or surgeons to notify, please indicate that there are no additional accounts, or indicate None or NA on the form. 4. Retain a copy of your Inventory Return Certification and product return forms for your records in the event of a compliance audit of your facility. Risk Manager Responsibilities: 1. Review this correction notice and ensure that affected personnel, including surgeons, are aware of the contents. 2. If you have affected product at your facility, assist your Zimmer Biomet sales representative and quarantine all affected product. Your Zimmer Biomet sales representative will remove the affected product from your facility. 3. If the product has been further distributed, provide your customers with this notice ensure documentation. 4. Complete Attachment 1 Certificate of Acknowledgement and send to CorporateQuality.PostMarket@zimmerbiomet.com. This form shall be returned even if you do not have affected products at your facility. 5. Retain a copy of the acknowledgeme
- K numbers
- K181171
- Harmonized identifiers (openFDA)
- Device name
- Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
- Medical specialty description
- Orthopedic
- Regulation number
- 888.3353
- Device class
- 2
- K number
- K920219, K051588, K935193, K062684, K202768, K934457, K190535, K915184, K120211, K990261, K060577, K191399, K120362, K242249, K892644, K182048, K182705, K181744, K935452, K033944, K240391, K945091, K965002, K161830, K192416, K011533, K192352, K971409, K971497, K991226, K093944, K964431, K934694, K100412, K211891, K915309, K945094, K210678, K992144, K121665 +495 more
- Registration number
- 1000577893, 3009888740, 9681642, 3003639920, 3010155661, 3013450937, 2183744, 1822565, 3016438761, 3043543260, 3009882462, 1057425, 3036756245, 3005913274, 3007334927, 8043792, 3013413393, 3014763043, 1450662, 2245304, 3005333358, 1020279, 3005751028, 3003998208, 9610726, 9610612, 1722511, 1721676, 1836357, 3010047454, 3008668801, 3007353762, 3014315560, 3009732568, 3002498892, 3023852420, 3012275107, 3004371426, 3020282716, 3018052045 +238 more
- FEI number
- 1000577893, 1000220733, 3009888740, 3003639920, 3013450937, 3010155661, 3000206435, 2183744, 1000306303, 3003015552, 3016438761, 3043543260, 3003070421, 1000149660, 3009882462, 3002806315, 3036756245, 3005913274, 3007334927, 1020279, 3013413393, 3014763043, 1450662, 2245304, 3005333358, 3005751028, 3003998208, 1721676, 3010047454, 3008668801, 3007353762, 3014315560, 3003051987, 3009732568, 3002498892, 3023852420, 1000395711, 3002808293, 3012275107, 3002807113 +238 more