Affixus Hip Fracture Nail, RH 130 DEG 11MM X 400MM
Check against the official notice below — it lists the full affected range.
Zimmer Biomet is recalling 638 units of the Affixus Hip Fracture Nail (RH 130 DEG 11MM X 400MM) distributed nationwide in the US as well as in Portugal and the Netherlands. During rework of a previous field action from April 17, 2017, the set screw and sleeve assembly were found to have shifted from their installed location. This misalignment could prevent the product from assembling properly with the mating screw and targeting jig.
The affected product has item number 814511400 and lot number 507300 with an expiration date of May 21, 2027. The recall source does not specify a remedy or recommended action for consumers who may have received this product.
Written by software from the official notice below. Not reviewed by a lawyer.
During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.
Reason for recall: During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig. Distribution: US nationwide distribution. Also Portugal and the Netherlands. Quantity: 638 units Lot/code info: Item No. 814511400; Lot No. (Exp. Date) UDI: 507300 (05/21/2027) UDI (01)00887868039188 (17)270521 (10)507300
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.