Recall Z-1132-2015
Zimmer Gmbh · initiated December 17, 2014
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
CoCr Femoral Head - A modular head component is used in conjunction with a femoral stem component for replacement of the proximal femur in total hip arthroplasty.
Codes / lots: Item numbers: 01.01012.384; 01.01012.385; 01.01012.386; 01.01012.387; 01.01012.388; 01.01012.444; 01.01012.445; 01.01012.446; 01.01012.447; 01.01012.448 Lot #'s: 2551762, 2542690, 2542691, 2543993, 2544892, 2544893, 2551930, 2551931, 2557054, 2558475, 2559787, 2563363, 2564657, 2568082, 2539887, 2540911, 2544894, 2544895, 2545830, 2545831, 2545832, 2545833, 2547043, 2547807, 2548952, 2551330, 2551860, 2551861, 2554798, 2554799, 2554800, 2558476, 2558477, 2559788, 2561617, 2562662, 2563364, 2563385, 2565407, 2566564, 2567294, 2542692, 2542693, 2544896, 2547044, 2548953, 2551932, 2553210, 2556029, 2559603, 2563386, 2539888, 2540926, 2548954, 2553419, 61487633, 61487634, 61636015, 61495961, 61495962, 61495963, 61562431, 61577697, 61608436, 61562432, 61577709, 61487635, 61562448
Reason for recall
Potential compromise of the inner sterile tray. If a compromised tray is detected, a delay in surgery may result. If undetected breach in both the inner and outer trays were to occur, and there is contamination present, a periprosthetic infection is possible, which could lead to revision.
FDA-determined cause: Package design/selection
Action taken
On 12/17/2014, URGENT MEDICAL DEVICE RECALL notifications were sent to the affected distributors and hospital Risk Managers with instructions for returning the affected product. All distributors were notified via electronic mail, and all hospital Risk Managers and distributors with affected inventory were also notified via courier. 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. For questions, call the customer call center at 1-800-348-2759.
Details
- Recall number
- Z-1132-2015
- Initiated
- December 17, 2014
- Posted by FDA
- February 20, 2015
- Terminated
- September 23, 2015
- Product code
- LPH – Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
- Quantity
- 1908
- Distribution
- Domestic: AK, AL, AR, AZ, CA, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MS, MA, MD, ME, MI, MN, MO, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY International: Canada, Japan
- Recalling firm
- Zimmer Gmbh, Winterthur
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1133-2015 Class II | Metasul Femoral Head - A modular head component is used in conjunction with a femoral…Potential compromise of the inner sterile tray. If a compromised tray is detected, a delay in surgery may… | 12/17/2014Terminated |
| Z-1134-2015 Class II | Biolox Delta Femoral Head - The BIOLOX delta Ceramic Femoral Head is used in conjunction…Potential compromise of the inner sterile tray. If a compromised tray is detected, a delay in surgery may… | 12/17/2014Terminated |
| Z-1135-2105 Class II | CoCr Femoral Head - indicated for hip arthroplasty for noncemented use in skeletally…Potential compromise of the inner sterile tray. If a compromised tray is detected, a delay in surgery may… | 12/17/2014Terminated |
| Z-1136-2015 Class II | Metasul Femoral Head - indicated for total hip arthroplasty for treatment of patient…Potential compromise of the inner sterile tray. If a compromised tray is detected, a delay in surgery may… | 12/17/2014Terminated |