—#137058

Product

Unilateral external fixation ankle clamp Product Usage: Unilateral external fixation for use treatment of bone conditions amenable to treatment by use of external fixation modality

FDA product code: KTT — Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K111376
Affected lot / code info: Part 14-450510 Lots:268000, 466170, and 813950

Why it was recalled

Ankle clamp was assembled incorrectly; the offset of the pin to the pivot point is reversed. This prevents complete range of motion and if pushed too far may loosen the pin from the bone. A revision surgery may be necessary to adequately reconnect the fixator to the bone.

Root cause (FDA determination)

Process control

Action the firm took

Biomet sent an URGENT MEDICAL DEVICE RECALL NOTICE letter dated May 1, 2015 to the affected distributors and implanting surgeons. The recall letter included a description of the reason for the recall, affected product, consignee responsibilities, and distributor instructions for responding to the formal recall notification. Consignees were instructed to return the affected product and continued monitoring of patients. Questions related to this notice should be directed to (574) 372-1570, Monday through Friday, 8 a.m. to 5 p.m.

Recalling firm

Firm: Biomet, Inc.
Address: 56 E Bell Dr, Warsaw, Indiana 46582-6989

Distribution

Distribution pattern: US Nationwide Distribution in the states of CA, TX, FL, NC, MI, GA.

Timeline

Recall initiated: 2015-05-01
Posted by FDA: 2015-06-09
Terminated: 2015-12-08
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #137058. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.