—#133917

Product

Zimmer Segmental System (ZSS) Cemented Stem / ZSS Cemented Stem, Smooth Stem Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non-Porous, Uncemented.

FDA product code: LZO — Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K101296
Affected lot / code info: Item No. 00-5852-052-10; Lot 62866438

Why it was recalled

PMMA coating does not meet specifications. Area of the stem may be missing PMMA coating.

Root cause (FDA determination)

Process control

Action the firm took

Zimmer sent an URGENT MEDICAL DEVICE RECALL - Lot Specific letter dated February 5, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Your Responsibilities 1. Review the notification and ensure affected personnel are aware of the contents. 2. Locate and remove from inventory the affected products identified above. 3. Return any affected product with missing PMMA coating per the PER process 4. Return the Notification Acknowledgment Form (Attachment 1) to corporatequality.postmarket@zimmer.com. 5. Please notify Zimmer if the hospital that you have distributed the affected product to has implanted the product. In addition, identify the surgeons that have used this product. 6. If after reviewing this notification you have further questions or concerns please call the customer call center at 1-877-946-2761 between 8:00 am and 5:00pm EST.

Recalling firm

Firm: Zimmer, Inc.
Address: 1800 W Center St, Warsaw, Indiana 46580-2304

Distribution

Distribution pattern: US Distribution to the state of TX

Timeline

Recall initiated: 2015-02-05
Posted by FDA: 2015-02-27
Terminated: 2015-09-23
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #133917. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.